WASHINGTON -- Monster Beverage Corp.'s energy drinks have been cited in deaths of five people in the past year, according to incident reports that doctors and companies submit to the U.S. Food and Drug Administration.
The reports said the victims consumed Monster drinks prior to their deaths, FDA spokeswoman Shelly Burgess said Monday. The FDA said the incidents, which are voluntarily reported, are considered to be allegations, and no conclusion is drawn until an investigation is completed.
The FDA reports are being used by parents in Maryland who sued Monster last week, claiming that the drinks led to caffeine toxicity that killed their 14-year-old daughter. Sen. Dick Durbin, D-Ill., is asking the FDA to consider caffeine limits on energy drinks after emergency-room visits involving such products jumped tenfold from 2005 through 2009.
The five death reports, and a sixth in 2009, were among 37 adverse reaction reports since 2004 that cited Monster drinks, according to an incident log that health professionals, companies and the public voluntarily recorded with the FDA. The agency has said it is working on draft guidelines to ensure that energy drinks are safe.
Shares of Corona, Calif.,-based Monster fell the most since 2008. Monster dropped 14 percent, to $45.73, at the close of New York trading, erasing all gains the stock had made this year.
The log of adverse incident reports was given to Bloomberg News by Kevin Goldberg, a lawyer representing the parents of the 14-year-old girl who died. The girl, Anais Fournier, had consumed two Monster drinks, according to a copy of the complaint filed last Wednesday in state court in Riverside, Calif.
Monster, the largest U.S. energy drink maker by sales volume, sold about $1.6 billion worth of such drinks last year, the majority of company revenue, according to data compiled by Bloomberg. Its energy drink sales have tripled since 2006.
"Over the past 16 years, Monster has sold more than 8 billion energy drinks, which have been safely consumed worldwide," the company said in an emailed statement sent through an outside spokesman, Evan Pondel. "Monster does not believe that its beverages are in any way responsible for the death of Ms. Fournier. Monster is unaware of any fatality anywhere that has been caused by its drinks."
Monster said it intends to vigorously defend itself against the suit and won't comment further.
Emergency-room visits involving energy drinks increased to 13,114 in 2009, with about half those trips made by patients 18 to 25 years old and also involving drugs or alcohol, according to a November report by the Substance Abuse and Mental Health Services Administration. The event reports linked to Monster claimed that some of the life-threatening illnesses were characterized by heart attack, chest pain and vomiting.
The Center for Food Safety Adverse Event Reporting System is used by the public to report illnesses that the user deems to be linked to a particular food, drug or dietary supplement. The claims, which serve as a signal to the FDA, don't prove causation, Ms. Burgess said.
Monster and competitors such as Red Bull aren't bound by FDA guidelines for caffeine in sodas, because energy drinks are often sold as dietary supplements. Monster doesn't list the amount of caffeine in its proprietary formula, only that the ingredient along with the plant extract guarana and the amino acid taurine are in the drink, the lawsuit said.
Soda typically can have as many as 71 milligrams of caffeine per 12 ounces for the FDA to consider it safe. The FDA may require companies to prove caffeine levels are safe if they exceed the guideline.
Caffeine in energy drinks often ranges from 160 milligrams to 500 milligrams a serving, the FDA said in an August letter responding to Mr. Durbin's call for greater industry regulation. Regulators are assessing the nation's caffeine intake to ensure that the amount in energy drinks is as safe as that in coffee, soda and tea, the FDA said earlier this year, after Mr. Durbin raised the issue in April.
Anais' parents are seeking damages in court in excess of $25,000, according to their complaint. The cause of the Dec. 23, 2011, death was "cardiac arrhythmia due to caffeine toxicity," according to the suit, which cited a state autopsy report.science